Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used
FDA device recall Z-1730-2024 · posted 2024-05-08 · Open, Classified
Recall details
- Recalling firm
- Vyaire Medical, Inc.
- Reason for recall
- Potential of the nozzle separating during patient use.
- Action taken
- Vyaire Medical issued an URGENT Field Safety Notice to its consignees on 04/08/2024 via email. The notice explained the issue, requested a pull out test for all affected devices to verify the adhesive is adequate prior to use. If the product was further distributed, the party distributing device was directed to notify those to whom the device was sent. For any additional questions or concerns, please contact Vyaire at GMBEMEA- FSCA-RDX-INTL@Vyaire.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BZC
- Quantity affected
- 649 devices
- Distribution
- US nationwide distribution.
- Date initiated
- 2024-04-08
- Date posted
- 2024-05-08
- Location
- Hochberg, Germany
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